The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus

The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study

This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Prednisone tablet 5mg; Drug: Omega-3 soft capsules 1000 mg

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).
2. Age between 30-60 years
3. Ability to complete the present clinical trial.

Exclusion Criteria:

1. Pregnant or breast feeding women (pregnancy test for women of child bearing age).
2. Lichenoid reactions caused by certain drugs or dental amalgam.
3. Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
4. Patient doesn't have hepatitis C [after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
5. Presence of candidiasis before treatment.
6. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.
7. Hypertensive patients
8. Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prednisone 50 mg tablet; This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.	Drug: Prednisone tablet 5mg; This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.; Other Names: Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy
Active Comparator: Omega-3 capsules 1000 mg; This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.	Drug: Omega-3 soft capsules 1000 mg; This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.; Other Names: Super Omega; Technopharma, Cairo, Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve quality of the life (Oral Health Impact Profile)	Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size and types (atrophic/erosive) of the lesions	Size and types of the lesions were examined at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy. Score 5 = white striae with erosive area more than I cm Score 4 = white striae with erosive area less than 1 cm Score 3 = white striae with atrophic area more than I cm Score 2 = white striae with atrophic area less than I cm Score I =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa	6 months
Pain score (Visual analogue scale (VAS)),	Pain score was recorded at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy. Scale 0: no pain: VAS=0 Scale 1: mild pain: 0< VAS≤3.5 Scale 2: moderate pain: 3.5 <VAS≤7 Scale 3: severe pain: 7< VAS≤10.	6 months
Recurrence of disease	Recurrence within the following 3 months was recorded.	3 months

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Enas Elgendy, ph.D, October 6 University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 26, 2015
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Corticosteroid; Oral Lichen Planus; Omega -3
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: Elgendy - 1